Cox wrote on CTIX today , see what happens.Still not a buy rec.yet
Cellceutix Corp.’s (OTCBB: CTIX) volume is still too small to officially recommend, but its price has doubled in recent months and trading is increasing. In the last few weeks, Cellceutix has announced two important developments that overcome a setup suffered with a contract manufacturer that failed.
First and foremost, company executives disclosed that they have received approval from the FDA to proceed with clinical trials of Kevetrin, their novel cancer drug that reactivates p53, the “guardian angel of the human genome.” Additionally, the Institutional Review Board and Scientific Review Committee at Harvard Cancer Center, the host hospital, have approved the protocol for the clinical trials. Normally, it takes months for IRB and SRC approvals after the FDA gives the go-ahead, which indicates the hospital is anxious to get the new drug into patients.
I’m following a number of breakthrough cancer drugs, and the Cellceutix drug is a critical part of the emerging multifront attack that I believe will defeat most, if not all, cancers. In past reports, I’ve explained the importance of p53 in controlling cancerous tumors and why scientists have been trying for decades to discover a drug that captures the power of the p53 gene expression.
In the simplest terms, people who don’t suffer from cancer all have functional p53 gene expression protecting their body from tumors. In cancer patients, however, p53 activity is damaged in some way. Cellceutix scientists believe their drug reactivates p53 in cancer patients. The protein attempts to repair the genetic damage that cancers inflict. If repairs cannot be made, the cancer cells are instructed to undergo apoptosis — cell suicide.
This means that it is nongenotoxic. It doesn’t harm DNA, though it may have minor side effects that pass with treatment. It also means that it can be given systemically and will work on the entire body, as opposed to one tumor site. This is a big deal.
Now that clinical trials are going to begin at one of the world’s most prestigious cancer centers, Harvard’s Dana-Farber and partner Beth Israel Deaconess Medical Center, Cellceutix is going to be far more visible to Big Pharma, which makes the company a prime acquisition target. If positive data are shown in clinical trials, Cellceutix could see an offer prior to end of Phase 2.
Cellceutix has made other strides in June. The company announced a meeting with the FDA that resulted in guidance from the regulatory agency to apply for a 505(b)(2) designation for their psoriasis drug, Prurisol. This 505(b)(2) designation allows Cellceutix to take Prurisol straight into Phase 2 clinical trials.
As a point of reference, Stiefel Laboratories, a GlaxoSmithKline company, agreed to spend approximately $350 million to acquire rights to skin-treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica. The drugs that GSK are buying are only topical treatments for skin conditions like psoriasis. Prurisol is an oral treatment that has shown remarkable results compared with standard care today. As a systemic internal treatment, rather than just an ointment that treats the symptoms of psoriasis, Prurisol is potentially much more valuable.
The bottom line is that Cellceutix could have two drugs with serious potential to become front-line treatments for their respective indication in clinical trials in the next eight-12 months. This is the team, incidentally, that helped developed another of my favorite companies, NanoViricides (OTCBB: NNVC). Kevetrin, however, is lead candidate, and I’d guess dosing will begin in the third quarter this year.
Yours transformational profits,
Patrick Cox
